BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8735690 · Received June 26, 2019

    Report

    Report Number
    3006948883-2019-00495
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 16, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9023837. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY OUR QUALITY ENGINEERS REVIEWED THE SAMPLE, AS WELL AS OUR AVAILABLE RETENTION SAMPLES. NONE OF THE RETENTION SAMPLES REVIEWED SUFFERED FROM A SIMILAR EVENT, AND A THROUGH REVIEW OF THE MANUFACTURING LINE WAS UNABLE TO IDENTIFY ANY POTENTIAL CONTRIBUTING FACTORS THAT MAY HAVE LEAD TO THE OBSERVED NON-CONFORMANCE. OUR ENGINEERING STAFF BELIEVES THE EVENT HAD TO OF OCCURRED POST PRODUCTION, DURING EITHER THE TRANSPORTATION OF STORAGE OF THE DEVICE. THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE CONFIRMED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM HAD NO CAP. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND NO NEEDLE CAP DURING THE PREPARATION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM HAD NO CAP. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND NO NEEDLE CAP DURING THE PREPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531290 BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9023837

    Patients

    Seq Age Sex Outcome Treatment
    1 Other